Transcranial Direct Current Stimulation (tDCS) in the Primary Motor Cortex in Healthy Individuals

Not Applicable

Completed

• Conditions: Basic Physiology; Brain Stimulation
• Interventions: Device: Placebo Sooma transcranial direct current stimulation device; Device: Sooma transcranial direct current stimulation device

• Registration Number: NCT04148547
• Lead Sponsor: Universidad Autonoma de Madrid

Brief Summary

The main aim of this study is to assess the short-term effects of active-tDCS (a-tDCS) on the M1 regarding sensorimotor variables such as discriminative sensation, pressure pain threshold and electromyographic activity compared with a sham-tDCS (s-tDCS) in healthy individuals. The main objective was to determine whether there were clinically relevant changes generated by tDCS and if they were superior to a sham intervention.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-30
• Status Verified: 2019-10
• Study First Submitted: 2019-10-30
• Study First Submitted QC: 2019-10-30
• Last Update Submitted: 2019-10-31
• Study First Posted: 2019-11-01
• Last Update Posted: 2019-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• asymptomatic participants
• men and women aged 18 to 65 years

Exclusion Criteria

• insomnia
• nausea
• headache
• pregnancy
• use of painkillers in the last 24 hours
• presence of metal inside the head
• pacemaker
• wound on the area of electrodes' application
• drug consumption; (j) recent application of tDCS
• psychiatric disease impeding understanding of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham transcranial direct current stimulation	Placebo Sooma transcranial direct current stimulation device	-
transcranial direct current stimulation	Sooma transcranial direct current stimulation device	-

Primary Outcome Measures

Name	Time	Method
Pressure pain threshold through an algometer	Change in pressure pain threshold immediately at the end of the intervention	Pressure pain threshold has been defined as the minimal amount of pressure at which a sense of pressure first changes to pain or discomfort
Tactile acuity threshold	Change in tactile acuity threshold immediately at the end of the intervention	Tactile acuity threshold is an important variable to know the somatosensory state and Von Frey monofilaments and Aesthesiometer were used
Muscle recruitment through electromyographic activity	Change in electromyographic activity immediately at the end of the intervention	The activity of surface electromyography (sEMG) during an isometric maximal voluntary contraction was measured in the biceps brachii and rectus femoris.

Trial Locations

Locations (1)

CSEU La Salle; 🇪🇸 Madrid, Spain